jdjones on DSKHWCL6B1PROD with NOTICES

22900 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 

was posted on the ONC Web site on 

March 25, 2011 and originally open for 

public comment through Friday, April 

22 at 11:59 p.m. (Eastern). This notice 

serves to announce that the public 

comment period for the Plan has been 

extended through Friday, May 6 at 11:59 

p.m. (Eastern). 

In order for your comments to be read 

and considered, you must submit your 

comment via the Federal Health IT Buzz 

Blog: http://www.healthit.gov/buzzblog/from-the-onc-desk/hit-strat-plan/. 

Dated: April 19, 2011. 

Erin Poetter, 

Office of Policy and Planning, Office of the 

National Coordinator for Health Information 

Technology. 

[FR Doc. 2011–9941 Filed 4–22–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

Ames Laboratory in Ames, IA, To Be 

Included in the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees from Ames Laboratory in 

Ames, Iowa, to be included in the 

Special Exposure Cohort under the 

Energy Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Ames Laboratory. 

Location: Ames, Iowa. 

Job Titles and/or Job Duties: All 

Department of Energy (DOE) employees, 

its predecessor agencies, and its 

contractors and subcontractors who 

worked in any area of the DOE facility. 

Period of Employment: January 1, 

1942 through December 31, 1970. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 877– 

222–7570. Information requests can also 

be submitted by e-mail to 

DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2011–9928 Filed 4–22–11; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI) To 

Identify and Obtain Relevant 

Information From Public or Private 

Entities With an Interest in 

Biovigilance 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This Request for Information 

(RFI) seeks to identify and obtain 

relevant information regarding the 

possible development of a publicprivate partnership (PPP) designed to 

facilitate the identification of risks and 

strategies to assure safety of the U.S. 

supply of blood and blood components, 

tissues, cells, and organs. This RFI is 

intended to inform the Department of 

Health and Human Services (HHS) 

regarding stakeholders, mechanisms, 

and approaches on issues related to 

developing and managing a PPP and 

scope of PPP activities. Replies are 

invited from (1) public or private 

entities with an interest in biovigilance, 

and (2) entities with experience and 

capabilities managing public-private 

partnerships (PPPs) in the biological 

sciences and public health domains. 

This RFI is for information and planning 

purposes only and is not a solicitation 

for applications or an obligation on the 

part of the U.S. Government to provide 

support for any ideas identified in 

response to it. Please note that the U.S. 

Government will not pay for the 

preparation of any information 

submitted or for its use of that 

information. 

DATES: All responses must be received 

no later than 4 p.m. EDT on June 9, 2011 

at the address listed below. 

ADDRESSES: All responses should be 

e-mailed to Biovigilance@hhs.gov 

(attention Dr. Jerry Holmberg). Please 

limit responses to 10 pages. Include in 

the subject line, the following 

information: 

• Name of the institution or site. 

• Respondent, title, and full contact 

information. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Jerry Holmberg, Senior Advisor for 

Blood Safety, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Tower Building, Suite 250, 

Rockville, MD 20852. 

SUPPLEMENTARY INFORMATION: In 2009, 

the Advisory Committee on Blood 

Safety and Availability (ACBSA) within 

the Department of Health and Human 

Services (HHS), Office of the Assistant 

Secretary of Health, reviewed and 

discussed a report on the current state 

of biovigilance. In that report 

(‘‘Biovigilance: Efforts to Bridge a 

Critical Gap in Patient Safety and Donor 

Health’’ http://www.hhs.gov/ash/ 

bloodsafety/biovigilance/index.html), 

biovigilance was defined as ‘‘a 

comprehensive and integrated national 

patient safety program to collect, 

analyze, and report on the outcomes of 

collection and transfusion and/or 

transplantation of blood components 

and derivatives, tissues, cells, and 

organs. This definition does not include 

vaccines, allergenic products, and most 

recombinant human proteins.’’ Safety 

surveillance for plasma derivatives, 

while a logical part of biovigilance, 

already falls under FDA mandated drug 

adverse event reporting and is not 

addressed in the current HHS initiative. 

Among the recommendations in that 

report was for HHS to develop an HHS 

action plan to support a national 

biovigilance program, integration of 

systems within government and private 

sectors, and steps to enhance 

mechanisms for surveillance. 

HHS is continuing its efforts to 

develop an action plan to support a 

national biovigilance program for blood 

and blood components, tissues, cells, 

and organs. As part of these efforts, HHS 

is exploring the feasibility of a PPP. 

HHS believes that a PPP potentially 

could serve as an appropriate 

mechanism for achieving the broad 

goals and mission of biovigilance. A 

PPP might provide the American public 

with a mechanism for leveraging and 

maximizing resources, for collaborating 

on research and problem solving, for 

creating new opportunities, and for 

advancing the Department’s public 

health mission as it relates to challenges 

associated with disease prevention 

(including emerging infectious diseases 

or EIDs), adverse events, and process 

improvements. 

Biovigilance is an area of growing 

importance, with a potential role in any 

of the following areas: 

• Identifying strategies for protecting 

recipients and living donor health;